Home FDA labels e5cb08fc-008c-4cbf-82be-8a3d2612e1bd FDA label e5cb08fc-008c-4cbf-82be-8a3d2612e1bd openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 50b44fd6-8747-448f-b951-234e7e17df4f
SPL ID e5cb08fc-008c-4cbf-82be-8a3d2612e1bd
Version 5
Effective date 2018-02-26
Source export date 2026-08-01
Source partition 13
Source file https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:37:04 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings WARNING Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Should be chewed. This product, as with all chewable tablets, is not recommended for children under age 4 due to risk of choking.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.